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Drugs for medical abortion: Where we are now

Drugs for medical abortion: Where we are now. Peter Hall Chief Executive Officer Concept Foundation Bangkok, Thailand and Geneva, Switzerland. What products are available for medical abortion? Making quality product available at an affordable price: Concept’s Access-to-

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Drugs for medical abortion: Where we are now

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  1. Drugs for medical abortion: Where we are now Peter Hall Chief Executive Officer Concept Foundation Bangkok, Thailand and Geneva, Switzerland International Consortium on Medical Abortion Lisbon, 2-4 March 2010

  2. What products are available for medical abortion? • Making quality product available at an affordable price: Concept’s Access-to- Medicines programme for medical abortion International Consortium on Medical Abortion Lisbon, 2-4 March 2010

  3. What products are available for medical abortion? • Making quality product available at an affordable price: Concept’s Access-to- Medicines programme for medical abortion International Consortium on Medical Abortion Lisbon, 2-4 March 2010

  4. Medical abortion is important – this we know • It offers a safe and effective choice of method for termination of pregnancy. • Choice of method is important not only for women but also to make service provision less problematic for many providers. • It encourages health systems to make abortion a primary care service. • It can make abortion: earlier; more accessible; safe; less traumatic; less expensive; and be provided by most healthcare workers. International Consortium on Medical Abortion Lisbon, 2-4 March 2010

  5. So “Where we are now” or is it “Where are we now?” THIRTY YEARS after Roussel-Uclaf undertook its clinical trials on mifepristone (RU-486) for early abortion, where are we now?Are affordable products of assured quality for medical abortion widely available to poor women throughout the world?Or do we have a critical healthcare technology which follows the “norm” where the rich can always access quality products and services but the poor remain without them? International Consortium on Medical Abortion Lisbon, 2-4 March 2010

  6. The world as seen by relative MMR International Consortium on Medical Abortion Lisbon, 2-4 March 2010

  7. Product availability - misoprostol • Searle (part of Pfizer), registered misoprostol (as Cytotec) worldwide, India, most of Africa, the Middle East and central Asia, for the prevention of gastric ulcers associated with NSAIDs. • Misoprostol is widely available as generic formulations and, in many countries, cheaply. • Has begun to be registered for obstetric indications in several countries but in few for termination of pregnancy. • Included on WHO EML for induction of labour, incomplete abortion; in combination with mifepristone for early abortion. International Consortium on Medical Abortion Lisbon, 2-4 March 2010

  8. Availability of drugs for medical abortion International Consortium on Medical Abortion Lisbon, 2-4 March 2010

  9. Product availability - misoprostol Ipas undertook a desk exercise which listed some 50 manufacturers of misoprostol worldwide. But excluded many countries. Likely to more than 60 manufacturers. (Fernandez MM et al. Int J Gyn Obs. 2009) International Consortium on Medical Abortion Lisbon, 2-4 March 2010

  10. Where are misoprostol products made? Finished products (misoprostol only) Argentina, Bangladesh, Brazil, China, Colombia, Egypt, France, India, Indonesia, Mexico, Nepal?, Russia, South Korea, Spain, Taiwan, UK, Uruguay, USA, Viet Nam, +? Active pharmaceutical ingredient China, India, Ireland(!), Taiwan, USA International Consortium on Medical Abortion Lisbon, 2-4 March 2010

  11. Product availability - mifepristone • Mifepristone has limited availability – is approved and sold in >40 countries. • Mifepristone API is expensive, relatively complex synthesis, small-scale and low yield; and small sales volume outside India and China. • In some countries, it remains so expensive, it cannot be provided in the public sector. In South Africa, it is $45/tablet. • Included on WHO EML, in combination with misoprostol for early abortion. International Consortium on Medical Abortion Lisbon, 2-4 March 2010

  12. Availability of drugs for medical abortion International Consortium on Medical Abortion Lisbon, 2-4 March 2010

  13. Product availability - mifepristone • Exelgyn (Europe, South Africa) and Danco (USA) serve high-income countries at high “market” prices. • Entry into these markets for developing country manufacturers comes with very high opportunity costs. (stringent regulations for drug approval) • Developing country manufacturers serve their own markets where: • Opportunity costs are lowest (China, India). • High opportunity rewards and large potential markets exist (China, India). • Ease of registration. International Consortium on Medical Abortion Lisbon, 2-4 March 2010

  14. Where are mifepristone products made? Finished products • China • France • India • USA • Viet Nam Active pharmaceutical ingredient • China • France • India International Consortium on Medical Abortion Lisbon, 2-4 March 2010

  15. Mifepristone and misoprostol in India International Consortium on Medical Abortion Lisbon, 2-4 March 2010

  16. Product availability But what is the overall situation on what misoprostol products are available, their quality, and the potential of misoprostol manufacturers to meet international quality and safety and efficacy requirements? And what do we know about the stability of misoprostol formulations in tropical climates or even above 25°C? Concept is undertaking a study with the support of Gynuity Health Projects. International Consortium on Medical Abortion Lisbon, 2-4 March 2010

  17. International Consortium on Medical Abortion Lisbon, 2-4 March 2010

  18. Conclusions of study • Most companies manufacture products according to outdated requirements that do not conform to CGMP, or even “older” GMP. Many have inadequate understanding of, and ability to implement and invest, in quality assurance. Some should be closed! • Most are not in a position to supply products into international markets, not having considered regulatory approval for their products outside their home markets. • This was for hormonal contraceptives – why would we expect misoprostol to be different? International Consortium on Medical Abortion Lisbon, 2-4 March 2010

  19. Regulatory requirements If an innovator product, must have complete: • Clinical module, with full clinical studies and expert clinical review. • Toxicology and preclinical module, with expert toxicology review. • Chemicals, manufacturing and controls module, detailing full manufacturing process, quality assurance (includes CGMP), API Drug Master Files. If a generic product must: • Demonstrate safety and efficacy and undertake bioequivalence studies against innovator product. • Chemicals, manufacturing and controls module, detailing full manufacturing process, quality assurance procedures (includes CGMP), API Drug Master File. Catch-22, the innovator is not registered for this indication. International Consortium on Medical Abortion Lisbon, 2-4 March 2010

  20. Regulatory dossiers approved by stringent drug regulatory agencies Mifepristone • Exelgyn (Nordic Trading): Europe, Tunisia, S Africa • Danco: USA Misoprostol • HRA Pharma: France, Tunisia Mifepristone + misoprostol • Sun Pharma: India, Nepal, Cambodia, Zambia. Under review by 15 EU/EFTA DRAs International Consortium on Medical Abortion Lisbon, 2-4 March 2010

  21. What products are available for medical abortion? • Making quality product available at an affordable price: Concept’s Access-to- Medicines programme for medical abortion International Consortium on Medical Abortion Lisbon, 2-4 March 2010

  22. What does Concept Foundation do? • Concept Foundation is a not-for-profit organization, based in Bangkok and Geneva, with the mission to: “ensure that low income women worldwide have access to sexual and reproductive health products of assured quality at the lowest possible cost .” • This goal is met through design and implementation of Access-to-Medicines (ATM) programmes for selected products for reproductive health, through the establishment and support of: Public-Private Partnerships (PPPs) with pharmaceutical companies; and a systematic and coordinated approach to product introduction. International Consortium on Medical Abortion Lisbon, 2-4 March 2010

  23. Getting from research to people Under its collaborative agreement with WHO, agreed to: • Price – Co-packaged product with preferential price to public sector, making it affordable to many more women. • Quality - Manufactured in USFDA/EMEA compliant facility, meeting international current Good Manufacturing Practice (cGMP). • Regulatory issues – Misoprostol used “off-label” (except France and India), regulatory agencies welcome formal registration of misoprostol for use in medical abortion; clinical part of registration dossier based on WHO clinical trials. • Ease of use – co-packaged product easier for both provider and woman. International Consortium on Medical Abortion Lisbon, 2-4 March 2010

  24. How does Concept Foundation achieve it? • Manages technology transfer and key components of pharmaceutical manufacturing. • Acts as “guardian” of product quality and access to public sector agencies at an affordable price, through specific agreement on quality, availability and pricing with the manufacturer. • Names licensee in its Lloyds liability insurance. • Monitors how public sector price is implemented in each country. International Consortium on Medical Abortion Lisbon, 2-4 March 2010

  25. How does Concept Foundation achieve it? • Concept provides and manages key components for pharmaceutical manufacturing and marketing, such as: technology transfer, cGMP protocols, data from pivotal clinical studies, GCP-compliant clinical research, ICH-compliant regulatory documentation, regulatory dossier submissions, and identifying importers and distributors. • In return, the commercial partner agrees to serve under-developed and normally unprofitable markets with products of assured quality at the lowest possible cost. • Concept Foundation negotiates a transparent ex-factory supply price for public sector agencies and ensures that appropriate strategies have been developed for the introduction of a product. International Consortium on Medical Abortion Lisbon, 2-4 March 2010

  26. Regulatory dossier Clinical module • Undertook additional analyses of data from WHO clinical trials; undertook bioequivalence studies against innovator products; prepared expert clinical review. Toxicology and preclinical module • Undertook additional genotoxicity studies; prepared expert toxicology review from published data of mifepristone and misoprostol and the preclinical part of dossier Completed dossier in an ICH-compliant format. International Consortium on Medical Abortion Lisbon, 2-4 March 2010

  27. What has been achieved? Collaborative agreement with WHO; creation of a PPP with Sun Pharma, India; and funding by DfID, Norad, Minbuza, Packard Foundation and an “anonymous donor” allowed development, registration and introduction of an affordable product of assured quality Medabon® Product website launched www.medabon.info International Consortium on Medical Abortion Lisbon, 2-4 March 2010

  28. Where is Medabon being registered? International Consortium on Medical Abortion Lisbon, 2-4 March 2010

  29. So “Where are we now?” THIRTY YEARS after Roussel-Uclaf undertook its clinical trials on mifepristone (RU-486) for early abortion, where are we now?Are affordable products of assured quality for medical abortion widely available to poor women throughout the world? No, some progress but….!Or do we have a critical healthcare technology which follows the “norm” where the rich can always access quality products and services but the poor remain without them? In many countries, the answer remains yes and is a key issue we MUST continue to address. International Consortium on Medical Abortion Lisbon, 2-4 March 2010

  30. Visit www.conceptfoundation.org and www.medabon.info International Consortium on Medical Abortion Lisbon, 2-4 March 2010

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